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OpenTrials
Completed

NCT Number: NCT01948011

Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

To investigate the Racecadotril pharmacokinetic linearity after single oral administration of 10, 30 and 60 mg as a suspension.

To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension) versus the reference sachet formulation (granules)

Completed

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Eurofins Optimed

Gières, 38610, France

About this study

This is a single center, open-label, single oral dose, 4-period cross-over study to assess the bioequivalence of a new formulation (suspension) in healthy male volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male,
  • 18 to 45 years old,
  • be certified as normal by a comprehensive clinical assessment (detailed medical history and a complete physical examination), arterial blood pressure (BP), heart rate (HR), an ECG and laboratory investigations (haematological, blood chemistry tests, urinalysis), the results of which are within the normal range and/ or judged by the investigator as clinically acceptable for healthy subjects,
  • Body Mass Index (BMI) between 18 and 28 kg/m2.

Exclusion criteria

  • History of cardiovascular, pulmonary gastro-intestinal, hepatic, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease.
  • Any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
  • Subject has used any drug including OTC products two weeks before the scheduled administration of study drug, except paracetamol (maximum 1g/day).

Treatment and study plan

Racecadotril suspension

Drug

Racecadotril suspension at 10, 30 and 60mg. Single oral dose.

Racecadotril granules

Drug

Racecadotril granules at 60mg. Single oral dose.

Primary outcomes

  1. Bio-equivalence

    Time frame: Total study duration per subject should be 6 weeks.

    Several blood sample will be collected at each period to investigate the racecadotril pharmacokinetic linearity and to evaluate the comparative bioavalibility.

    4-period, cross over, single oral dose at each period.

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study title

Study of the Racecadotril Linearity After Single Administrations of 10, 30 and 60 mg of a New Racecadotril Formulation (Suspension) by Oral Route and Evaluation of the Comparative Bioavailability of This New Formulation Versus the Sachet Formulation (Granules) After a 60 mg Single Oral Administration in Healthy Male Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2013
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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